Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma

Phase 2

Completed

• Conditions: Malignant Glioma; Brain Cancer
• Interventions: Other: radiotherapy (RT) in combination with temozolomide and bevacizumab

• Registration Number: NCT00782756
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to test the safety of a new plan for treating glioblastoma. The usual first treatment for glioblastoma is to give focused radiation over 6 weeks in combination with a chemotherapy called temozolomide. In this study the radiation will be given over 2 weeks in combination with temozolomide and another drug, bevacizumab, will also be given. Our idea is that this treatment plan may attack both the tumor and the blood vessels feeding the tumor more effectively. This study will look at what effects, good or bad, this approach has on the patient and the tumor.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-28
• Study First Submitted: 2008-10-29
• Study First Submitted QC: 2008-10-29
• Study First Posted: 2008-10-31
• Status Verified: 2017-03
• Primary Completion: 2017-03-23
• Study Completion: 2017-03-23
• Results First Submitted: 2017-12-13
• Results First Submitted QC: 2018-01-10
• Last Update Submitted: 2018-01-10
• Results First Posted: 2018-02-06
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Pathologic diagnosis of glioblastoma or grade IV glioma.
• Tumor volume should be less than 60 cc (approximately 5cm maximum diameter).
• Age > or = to 18
• KPS ≥70
• Granulocyte count >1.5 X 10 9/L
• Platelet count >99 X 10 9/L
• SGOT < 2.5X upper limit of normal (ULN)
• Serum creatinine < 2X ULN
• Bilirubin < 2X ULN
• All patients must sign written informed consent

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Exclusion Criteria

• Any prior chemotherapy, radiotherapy and biologic therapy for glioma.
• Any prior experimental therapy for glioma.
• Multicentric glioma
• Other concurrent active malignancy (with the exception of cervical carcinoma in situ or basal cell ca of the skin).
• Serious medical or psychiatric illness that would in the opinion of the investigator interfere with the prescribed treatment.
• Pregnant or breast feeding women.
• Refusal to use effective contraception
• Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg)
• Prior history of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association (NYHA) Grade II or greater congestive heart failure
• History of myocardial infarction or unstable angina within 12 months prior to Day 1
• History of stroke or transient ischemic attack
• Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
• History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of treatment or anticipation of need for major surgical procedure during the course of the study
• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
• History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
• Serious, non-healing wound, active ulcer, or untreated bone fracture
• Proteinuria as demonstrated by a UPC ratio ≥ 1.0 at screening
• Known hypersensitivity to any component of bevacizumab

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RT, with temozolomide and bevacizumab	radiotherapy (RT) in combination with temozolomide and bevacizumab	This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	through study completion, an average of 1 year	Safety assessments and toxicity grading will follow CTCAE Version 4 Grade

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	through study completion, an average of 1 year
Neurocognitive Outcome	through study completion, an average of 1 year

Trial Locations

Locations (3)

Memoral Sloan Kettering Cancer Center; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan-Kettering Cancer Center at Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States